Molar-Incisor Hypomineralization (MIH)NCT07336212
Impact of Glass-Hybrid Restoration on Occlusal Force Distribution and Masticatory Muscle Activity in Children With Molar-Incisor Hypomineralization
A study testing Glass-Hybrid Restoration in people with Molar-Incisor Hypomineralization (MIH), run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This prospective pilot study evaluates the effect of restoring symptomatic, carious molar-incisor hypomineralization (MIH)-affected permanent molars using a glass-hybrid restorative material on occlusal force distribution and masticatory muscle activity. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Molar-Incisor Hypomineralization (MIH)
- What is being tested?
- Glass-Hybrid Restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 4 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7 to 13 years
- Diagnosis of molar-incisor hypomineralization (MIH) according to the criteria of Ghanim et al.
- Presence of at least two MIH-affected first permanent molars with post-eruptive enamel breakdown requiring restorative treatment
- Presence of dentin hypersensitivity in the affected molars
- Ability to comply with T-Scan and surface electromyography (sEMG) recording procedures
- Written informed consent obtained from parents or legal guardians, and assent from the child
Who cannot join
- Previous or ongoing orthodontic treatment
- Presence of craniofacial anomalies or syndromes
- Diagnosis of temporomandibular disorders
- Parafunctional habits (e.g., bruxism)
- Clinically evident facial asymmetry
- Malocclusions such as crossbite or open bite
- Systemic diseases or medications affecting neuromuscular function -Inability to cooperate with functional assessment procedures -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Restorative Treatment on Occlusal Characteristics and Masseter Muscle Activity in Children With Molar-Incisor Hypomineralization: A T-Scan and sEMG Pilot Study
This prospective pilot study evaluates the effect of restoring symptomatic, carious molar-incisor hypomineralization (MIH)-affected permanent molars using a glass-hybrid restorative material on occlusal force distribution and masticatory muscle activity. Digital occlusal analysis using the T-Scan system and surface electromyography (sEMG) recordings of the masseter and anterior temporalis muscles are performed before treatment and three months after restoration. Hypersensitivity is assessed using the Schiff Cold Air Sensitivity Scale.
Read the detailed description
This single-arm prospective pilot study investigates whether restorative rehabilitation of MIH-affected permanent molars leads to functional improvements in occlusal balance and neuromuscular activity. Children aged 7-13 years with symptomatic MIH requiring restorative treatment undergo standardized glass-hybrid restorations. Functional occlusal analysis is conducted using the T-Scan Novus system to assess lateral occlusal force distribution, while bilateral surface electromyography (sEMG) evaluates masseter and temporalis muscle activity during maximum voluntary clenching. Dentin hypersensitivity is assessed using the Schiff Cold Air Sensitivity Scale. Pre- and post-treatment outcomes are compared to explore early functional adaptation following MIH rehabilitation.
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Being tested
- Glass-Hybrid Restoration
- Keywords
- Pediatric Dentistry, MIH, Occlusal Balance, Electromyography, T-Scan, sEMG, Molar-Incisor Hypomineralization, Occlusal Force Distribution, Glass-Hybrid Restoration
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass-Hybrid RestorationProcedure or surgery
Selective caries removal followed by bulk-fill glass-hybrid restoration of MIH-affected first permanent molars using Equia Forte®. The procedure is performed by a calibrated pediatric dentist according to the manufacturer's instructions. Occlusion is checked and adjusted after restoration prior to functional assessments.
| Study group | Role | What they receive |
|---|---|---|
| Glass-Hybrid Restoration in MIH-Affected Molars | Experimental | Participants receive restorative treatment of symptomatic, carious first permanent molars affected by molar-incisor hypomineralization using a bulk-fill glass-hybrid restorative material (Equia Forte®). Functional assessments, including digital occlusal analysis with the T-Scan system and surface electromyography (sEMG) recordings of the masseter and anterior temporalis muscles, are performed at baseline and 3 months after restoration. Receives: Procedure: Glass-Hybrid Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral Occlusal Force Distribution (LOFD)
Change in lateral occlusal force distribution assessed using the T-Scan digital occlusal analysis system during maximum voluntary clenching. The primary variable is the absolute deviation from ideal 50-50 bilateral force distribution, calculated at baseline and 3 months after glass-hybrid restoration.
Measured: Baseline and 3 months post-treatment
Secondary outcomes (2)
Masticatory Muscle Activity Symmetry
right-left asymmetry indices of the masseter and anterior temporalis muscles measured using surface electromyography (sEMG) during maximum voluntary clenching.
Measured: Baseline and 3 months post-treatment
Dentin Hypersensitivity
Dentin hypersensitivity of MIH-affected molars assessed using the Schiff Cold Air Sensitivity Scale following an air-blast stimulus.
Measured: Baseline and 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start5 Jan 2026
- Primary completion30 Apr 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Molar-Incisor Hypomineralization (MIH)Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336212
- Sponsor's protocol ID
- Pedo-occlusion
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savas AN, Durmus B, Gozler S, Kargul B. Short-Term Changes in Occlusal Force Distribution and Masticatory Muscle Activity After Restorative Treatment in Children with Molar-Incisor Hypomineralization: An Exploratory Pilot Study. Children (Basel). 2026 Sep 16;13(9):1256. doi: 10.3390/children13091256.
PubMed 42794276
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Restorative Treatment on Occlusal Characteristics and Masseter Muscle Activity in Children With Molar-Incisor Hypomineralization: A T-Scan and sEMG Pilot Study
- ClinicalTrials.gov ID
- NCT07336212
- Acronym / sponsor ID
- Pedo-occlusion
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Keywords
- Pediatric Dentistry, MIH, Occlusal Balance, Electromyography, T-Scan, sEMG, Molar-Incisor Hypomineralization, Occlusal Force Distribution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective pilot study evaluates the effect of restoring symptomatic, carious molar-incisor hypomineralization (MIH)-affected permanent molars using a glass-hybrid restorative material on occlusal force distribution and masticatory muscle activity. Digital occlusal analysis using the T-Scan system and surface electromyography (sEMG) recordings of the masseter and anterior temporalis muscles are performed before treatment and three months after restoration. Hypersensitivity is assessed using the Schiff Cold Air Sensitivity Scale.
Detailed description
This single-arm prospective pilot study investigates whether restorative rehabilitation of MIH-affected permanent molars leads to functional improvements in occlusal balance and neuromuscular activity. Children aged 7-13 years with symptomatic MIH requiring restorative treatment undergo standardized glass-hybrid restorations. Functional occlusal analysis is conducted using the T-Scan Novus system to assess lateral occlusal force distribution, while bilateral surface electromyography (sEMG) evaluates masseter and temporalis muscle activity during maximum voluntary clenching. Dentin hypersensitivity is assessed using the Schiff Cold Air Sensitivity Scale. Pre- and post-treatment outcomes are compared to explore early functional adaptation following MIH rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glass-Hybrid Restoration in MIH-Affected Molars | Experimental | Procedure: Glass-Hybrid RestorationParticipants receive restorative treatment of symptomatic, carious first permanent molars affected by molar-incisor hypomineralization using a bulk-fill glass-hybrid restorative material (Equia Forte®). Functional assessments, including digital occlusal analysis with the T-Scan system and surface electromyography (sEMG) recordings of the masseter and anterior temporalis muscles, are performed at baseline and 3 months after restoration. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 7 to 13 years
- Diagnosis of molar-incisor hypomineralization (MIH) according to the criteria of Ghanim et al.
- Presence of at least two MIH-affected first permanent molars with post-eruptive enamel breakdown requiring restorative treatment
- Presence of dentin hypersensitivity in the affected molars
- Ability to comply with T-Scan and surface electromyography (sEMG) recording procedures
Key exclusion criteria (7 listed)
- Previous or ongoing orthodontic treatment
- Presence of craniofacial anomalies or syndromes
- Diagnosis of temporomandibular disorders
- Parafunctional habits (e.g., bruxism)
- Clinically evident facial asymmetry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glass-Hybrid RestorationSelective caries removal followed by bulk-fill glass-hybrid restoration of MIH-affected first permanent molars using Equia Forte®. The procedure is performed by a calibrated pediatric dentist according to the manufacturer's instructions. Occlusion is checked and adjusted after restoration prior to functional assessments. | Procedure or surgery | Glass-Hybrid Restoration in MIH-Affected Molars |
Primary outcome
Lateral Occlusal Force Distribution (LOFD)
Time frame: Baseline and 3 months post-treatment
Change in lateral occlusal force distribution assessed using the T-Scan digital occlusal analysis system during maximum voluntary clenching. The primary variable is the absolute deviation from ideal 50-50 bilateral force distribution, calculated at baseline and 3 months after glass-hybrid restoration.
2 secondary outcomes
Masticatory Muscle Activity Symmetry
Time frame: Baseline and 3 months post-treatment
Dentin Hypersensitivity
Time frame: Baseline and 3 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 42794276Savas AN, Durmus B, Gozler S, Kargul B. Short-Term Changes in Occlusal Force Distribution and Masticatory Muscle Activity After Restorative Treatment in Children with Molar-Incisor Hypomineralization: An Exploratory Pilot Study. Children (Basel). 2026 Sep 16;13(9):1256. doi: 10.3390/children13091256.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glass-Hybrid Restoration in people with Molar-Incisor Hypomineralization (MIH), run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lateral Occlusal Force Distribution (LOFD) (time frame: Baseline and 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07336212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.